Khatri et al. The TRUST (EvaluaTion of Bladder Function in Relapsing-Remitting MUltiple Sclerosis Patients Treated with Natalizumab) Observational Study. Int J MS Care. 2014 Spring;16(1):40-7.
Treatment with natalizumab results in a spontaneous improvement in bladder function. #MSBlog #MSResearch
“The open-label study below shows that in MSers with more advanced disease (mean EDSS 4.6) and active MS that starting on natalizumab resulted in an improvement in bladder function. This is an open-label study and hence there could be a superimposed placebo-effect accounting for all of, or some of, the positive effect. This data, however, mirrors our clinical experience with natalizumab and is supported by other data showing that about a third of MSers starting natalizumab notice an improvement in disability. Why? I suspect that by switching off inflammation it allows the nervous system to repair itself. This is an example of repair, albeit self-repair at work. It also suggests that for reparative, or remyelination, strategies to work in MS we are going to have to switch off the inflammatory component of this disease first. If we don’t, any repaired myelin sheaths or nerve fibres are likely to get damaged in the next round of inflammation. This is why reparative strategies have to be added on to treatments that halt the disease process.”
“As this data is not class 1 evidence, I have asked Biogen-Idec to look at the data from the placebo-controlled phase of their pivotal trial to see if MSer randomised to natalizumab had fewer bladder related adverse events, for example UITs, and whether or not they required less concomitant medication to treat bladder symptoms. If the data shows this then this will support the strategy of early effective treatment to prevent, or at least delay bladder dysfunction in MS. The question is whether or not other treatments have the same effect as natalizumab.”
Background: Bladder dysfunction is a common symptom of MS. This study was designed to evaluate effects of natalizumab on bladder function in RRMSers.
Methods: The TRUST (EvaluaTion of Bladder Function in Relapsing-Remitting MUltiple Sclerosis Patients Treated with Natalizumab) study was an open-label, single-arm, two-center study. Natalizumab-naive MSers with disabling bladder dysfunction and initiating natalizumab were enrolled and followed for 6 months. The primary endpoint was change in the Urogenital Distress Inventory short form (UDI-6) score from baseline. Change in Incontinence Impact Questionnaire short form (IIQ-7) score from baseline was a secondary endpoint.
Results: Thirty MSers were enrolled. Mean baseline characteristics were age 49.9 years, Expanded Disability Status Scale score 4.6, number of relapses in previous year 2.4, UDI-6 score 10.4, and IIQ-7 score 12.3. Mean changes in UDI-6 and IIQ-7 scores were significantly improved from baseline beginning at week 4 and up to week 24; mean improvements at 24 weeks were 4.4 (P < .0001) and 4.9 (P = .0005) points, respectively. At week 24, 85.7% and 78.6% of patients demonstrated improvements from baseline in UDI-6 and IIQ-7 scores, respectively.
Conclusions: Incontinence-related quality of life as measured by UDI-6 and IIQ-7 scores improved significantly during natalizumab treatment.